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Advance MalignanciesPhase 1NCT02326441

Safety, Tolerability & PK of KX2-361 in Subjects w Adv. Malignancies Refractory to Conventional Therapies

A Phase 1 study testing KX2-361 in people with Advance Malignancies, run by Athenex, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety and tolerability of the study drug KX2-361 and to determine how much of the study drug enters the bloodstream, in patients with advanced malignancies that have not responded to conventional therapies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advance Malignancies
What is being tested?
KX2-361
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
3 sitesUnited States
Study dates
Dec 2014to 23 May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent.
  • Adults ≥ 18 years of age.
  • Dose Escalation Cohort only:
  • Confirmed advanced solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective; subjects with progressive brain metastases are also eligible.
  • OR Confirmed Histological/cytological hematological malignancy that is refractory to/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists.
  • OR Confirmed high grade glioma (grade 3and4) that is relapsed/refractory to standard therapies and who have progressive disease following radiation therapy. Patients with any number of prior treatments are allowed.
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  • Expansion Cohort only:
  • Patients with high grade glioma (grade 3 and 4) that are refractory to standard therapies, and who have progressive disease following radiation therapy. Patients with any number of prior treatments are allowed.
  • ECOG performance status of 0-2, Karnofsky Performance Status ≥60 (for glioma subjects).
  • Life expectancy of at least 12 weeks.
  • The following laboratory values:
  • ANC ≥ 1.5 x 10⁹/L
  • Platelets ≥ 100 x 10⁹/L
  • Hemoglobin (Hgb) > 10 g/dL
  • Serum total bilirubin ≤ 1.5 x ULN
  • ALT and AST ≤ 3.0 x ULN (subjects with known liver metastases may have AST and ALT ≤ 5.0 x ULN)
  • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (using Cockcroft and Gault method) > 60 mL/min)
  • Willingness to use acceptable birth control. Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female subjects of child-bearing potential must have a negative pregnancy test.

Who cannot join

  • Subjects who have not recovered to Grade 0 or 1 toxicity from previous anti-cancer treatments or previous investigational agents.
  • Subjects who have received investigational agents within 28 days of the first day of study drug.
  • Subjects with primary CNS malignancy other than high grade glioma (Grade 3 or 4)
  • Subjects who have received extensive radiation therapy, including sternum, pelvis, scapulae, vertebrae or skull, within 4 weeks of the first day of study drug or received palliative low dose radiation therapy limited to limbs within 1 week of the first day of study drug, or subjects who have not recovered from side effects of such therapy.
  • Subjects who are currently taking or have received hormones (eg, estrogen or progesterone) within 7 days the first dose of study drug. Note: Luteinizing hormone-releasing hormone (LHRH) analogs are permissible.
  • Subjects who are using moderate or strong CYP450 3A4 modulators (with the exception of antifungal agents listed in Appendix 2) within 5 half-lives before the first dose of study drug.
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  • Subjects who are using prescription or OTC medications (including, for example, proton pump inhibitors, H2 antagonists or calcium carbonate) that reduce or neutralize gastric acidity within 5 half lives before the first dose of study drug. Use of these medications for supportive care after cycle 1 is permitted.
  • Subjects who had major surgery within 4 weeks of the first day of study drug.
  • Subjects who had major surgery to the upper gastrointestinal tract, or who have a history of inflammatory bowel disease, malabsorption syndrome, or other medical condition that may interfere with oral drug absorption.
  • Subjects with a history of intestinal perforation, colitis, clinically significant gastrointestinal bleeding or intestinal obstruction within one year prior to enrollment.
  • Subjects with signs or symptoms of other major diseases including, but not limited to: end organ failure, major chronic illnesses other than cancer, coagulation disorders, hemolytic conditions (eg, sickle cell disease ) or active infections that, in the opinion of the investigator, make it undesirable for the subject to participate in the study.
  • Subjects who have a history of major cardiac or neurologic disease including, but not limited to, angina pectoris, symptomatic coronary artery disease, uncontrolled hypertension (at time of study entry), New York Heart Association (NYHA) Class III or IV congestive heart failure, confirmed significant cardiac conduction abnormalities (including QTc > 0.45 sec) or arrhythmias, myocardial infarction within 12 months, cerebrovascular accidents, or transient ischemic attacks.
  • Other conditions which could jeopardize the subject's ability to comply with the protocol including but not limited to dementia, psychosis, or other major psychiatric disorder.
  • Subjects with a known history of hepatitis B or C or human immunodeficiency (HIV) infection.
  • Subjects who require therapeutic doses of anticoagulants.
  • Subjects who require the use of granulocyte colony stimulating factors (GCSF) for prophylaxis of neutropenia.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cleveland Clinic, Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • UTHSCSA Cancer Therapy and Research Center

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects With Advanced Malignancies That Are Refractory to Conventional Therapies

The purpose of this study is to determine the safety and tolerability of the study drug KX2-361 and to determine how much of the study drug enters the bloodstream, in patients with advanced malignancies that have not responded to conventional therapies.

Being tested
KX2-361
Keywords
advanced malignancies, refractory therapies, phase 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KX2-361Drug

Study groups in NCT02326441
Study groupRoleWhat they receive
KX2-361ExperimentalNot described
Receives: Drug: KX2-361

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Define MTD

    The Maximum Tolerated Dose is defined as one dose level below where two or more subjects experienced a dose limiting toxicity (DLT).

    Measured: 12 months

Secondary outcomes (3)

  1. Safety and Tolerability assessed by adverse events and changes in laboratory parameters

    Patient incidence of adverse events will be displayed by dose group and by system organ class. Adverse events will also be summarized by severity and relationship to the study drug. Laboratory parameters assessed will include vital signs, history and PE, assessment of toxicity, complete blood count w differentials and reticulocytes, serum chemistry (incl. RDB, LFT serum amylase and serum lipase), PT (or INR/PTT), urinalysis, and ECG assessment.

    Measured: 24 months

  2. Pharmacokinetics (rofile pharmacokinetic outcome measures, e.g. Cmax, Tmax, AUCt, AUC0-inf, t½, CL, and Css)

    Plasma concentrations of KX2-361 will be analyzed to determine profile pharmacokinetic outcome measures, e.g. Cmax, Tmax, AUCt, AUC0-inf, t½, CL, and Css etc.

    Measured: 24 months

  3. Activity in escalation and expansion cohorts (according to the RECIST criteria, CHESON criteria, or the Modified RANO)

    Activity response for the Dose Escalation Cohort portion of the study will be assessed by the investigator according to the RECIST criteria, CHESON criteria, or the Modified RANO criteria. The Expansion Cohort will utilize the Modified RANO criteria only for response measurements.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJul 2017
  4. Study completion23 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326441
Sponsor's protocol ID
KX02-01-13
Status last verified
Jan 2019
First submitted
10 Dec 2014
Last updated
15 Jan 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KX2-361 in people with Advance Malignancies, run by Athenex, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Define MTD (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02326441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.

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